Certificaciones

Cleared by the U.S. Food and Drug Administration for use as a medical examination glove. This clearance verifies the product meets FDA performance standards for medical devices.

International standard for quality management systems. Demonstrates consistent ability to provide products that meet customer and regulatory requirements.

Standard specification for nitrile examination gloves for medical application. Sets requirements for dimensions, tensile strength, and barrier performance.

Standard specification for poly(vinyl chloride) gloves for medical application. Defines performance requirements for vinyl examination gloves.

European Conformity marking indicating the product meets EU health, safety, and environmental protection requirements for the European market.

European standard for medical gloves for single use. Covers dimensions, freedom from holes, physical properties, and biological evaluation.

European standard for protective gloves against dangerous chemicals and micro-organisms. Specifies requirements for penetration, permeation, and degradation resistance.

Acceptable Quality Level 1.5 — the international standard for pinhole testing of medical examination gloves. Indicates stringent quality control with a maximum defect rate of 1.5%.